Secondary Outcomes

Eligibility Criteria

Male or female participants from 20 years up to 55 years old.

Inclusion Criteria:
- Age 20-55 years
- Naive or previously hepatitis B-vaccinated males or females
- Normal and healthy as determined by medical history, physical exam, vital signs and
clinical laboratory tests
- Subject must meet all required/recommended subject suitability criteria that pertain
to normal source plasma donors with the following exceptions.
- Subjects who previously tested positive for HBsAg may be accepted into the anti-HBs
program provided they now test negative and meet all other normal donor suitability
criteria.
- Written informed consent.
Exclusion Criteria:
- Subjects who have received a hepatitis vaccination in the previous six months.
- History of hypersensitivity to yeast or any component of the Engerix-B® vaccine.
- History of hypersensitivity to any hepatitis B-containing vaccine.
- Use of any investigational product within the past 30 days or during the course of
the study.
- Use of steroids or immunosuppressives during the study period.
- Subjects who have received immunosuppressive therapy (including systemic steroids)
within 30 days before study entry
- Subjects who have received cytotoxic therapy (in the previous 5 years prior to study
entry)
- Received parenteral immune globulin products or blood products within 3 months before
study entry with the following exceptions (as specified by plasma center procedures):
- Rho (D) immune globulin (e.g. RhoGAM or WinRho) within 6 weeks before study entry;
- Pertussis immune globulin: no exclusion
- Past, present, or suspected IV drug use
- Positive HIV, HBV* or HCV test result (*except as described above in the Inclusion
Criteria section)
- Subjects with autoimmune disease (such as, but not limited to demyelinating disease)
- Subjects with cancer, heart disease (including hospitalization for myocardial
infarction, arrhythmia, syncope, congestive heart failure), uncontrolled
hypertension, uncontrolled insulin-dependent diabetes mellitus, seizures, kidney
disease
- Severely or morbidly obese, or higher obesity classification, which corresponds to
BMI of 35 or higher
- Pregnancy or lactation (females must have a negative pregnancy test prior to each
vaccination).